Using a Benefit–Risk Analysis Approach to Capture Regulatory Decision Making: Melanoma-Reference-Cited by-同舟云学术

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Using a Benefit–Risk Analysis Approach to Capture Regulatory Decision Making: Melanoma

Published:2019-05-21 Issue:1 Volume:106 Page:123-135
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Raju G. K.¹²,Gurumurthi Karthik¹,Domike Reuben¹³,Theoret Marc R.⁴,Pazdur Richard⁴,Woodcock Janet⁴

Affiliation:

1. Light Pharma, Inc. Cambridge Massachusetts USA

2. Massachusetts Institute of Technology Cambridge Massachusetts USA

3. Brigham Young University Provo Utah USA

4. Center for Drug Evaluation and ResearchUS Food and Drug Administration Silver Spring Maryland USA

Funder

U.S. Food and Drug Administration

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1461

Reference57 articles.

1. US Food and Drug Administration.Benefit‐risk assessment in drug regulatory decision‐making (2018). Accessed March 13 2019.

2. The PCAST Report: Impact and Implications for the Pharmaceutical Industry

3. The PCAST Report on Pharmaceutical Innovation: Implications for the FDA

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1. A framework for assessing the impact of accelerated approval;PLOS ONE;2022-06-24

2. A Framework for Assessing the Impact of Accelerated Approval;2022-02-15

3. Multi-Criteria Decision Analysis for Benefit-Risk Analysis by National Regulatory Authorities;Frontiers in Medicine;2022-01-12

4. The Integrated Review: FDA Modernizes the Review of New Drug Marketing Applications;Therapeutic Innovation & Regulatory Science;2020-11-24

5. Patient-Centered Approach to Benefit–Risk Characterization Using Number Needed to Benefit and Number Needed to Harm: Advanced Non–Small-Cell Lung Cancer;JCO Clinical Cancer Informatics;2020-09

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